Contains Nonbinding Recommendations Draft Guidance on ; Elvitegravir; ; Fumarate

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs.

Active Ingredient: Cobicistat; Elvitegravir; Emtricitabine; Tenofovir alafenamide fumarate

Dosage Form; Route: Tablet; oral

Recommended Studies: Two studies

1. Type of study: Fasting Design: Single-dose, two-way crossover in-vivo Strength: 150 mg; 150 mg; 200 mg; EQ 10 mg base Subjects: Healthy males and non-pregnant, non-lactating females. Additional Comments: None ______

2. Type of study: Fed Design: Single-dose, two-way crossover in-vivo Strength: 150 mg; 150 mg; 200 mg; EQ 10 mg base Subjects: Healthy males and non-pregnant, non-lactating females. Additional Comments: None ______

Analytes to measure (in appropriate biological fluid): Cobicistat; Elvitegravir; Emtricitabine; and Tenofovir alafenamide in plasma

Bioequivalence based on (90% CI): Cobicistat; Elvitegravir; Emtricitabine; and Tenofovir alafenamide

Waiver request of in-vivo testing: Not Applicable

Dissolution test method and sampling times: The dissolution information for this drug product can be found on the FDA-Recommended Dissolution Methods website, available to the public at the following location: http://www.accessdata.fda.gov/scripts/cder/dissolution/. Conduct comparative dissolution testing on 12 dosage units each of all strengths of the test and reference products. Specifications will be determined upon review of the abbreviated new drug application (ANDA).

Recommended Oct 2016; Revised Oct 2017